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Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD

This study has been completed.
Sponsor:
Information provided by:
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT00500071
First received: July 10, 2007
Last updated: January 14, 2011
Last verified: January 2011
History of Changes
Results First Received: May 26, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Attention Deficit Hyperactivity Disorder
Intervention: Drug: Vyvanse (lisdexamfetamine dimesylate)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study had three phases; 1)screening and wash-out; 2) dose-optimization (5 weeks) and maintenance (2 weeks); 3) 30-day safety follow-up. Dosing ranged from 20-70 mg once daily of Vyvanse.

Reporting Groups
  Description
Vyvanse Lisdexamfetamine dimesylate (LDX)

Participant Flow for 3 periods

 Period 1:   Screening and Washout Phase
    Vyvanse  
STARTED     318  
COMPLETED     317  
NOT COMPLETED     1  
Protocol Violation                 1  

Period 2:   Dose-optimization and Maintenance Phase
    Vyvanse  
STARTED     317 [1]
COMPLETED     295  
NOT COMPLETED     22  
Adverse Event                 13  
Protocol Violation                 2  
Lack of Efficacy                 2  
Withdrawal by Subject                 1  
Lack of protocol compliance                 4  
[1] Safety population (i.e., received at least one dose of study medication)

Period 3:   30-day Safety Follow-up
    Vyvanse  
STARTED     295  
COMPLETED     278  
NOT COMPLETED     17  
Lost to Follow-up                 17  



  Baseline Characteristics
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Reporting Groups
  Description
Vyvanse Lisdexamfetamine dimesylate (LDX)

Baseline Measures
    Vyvanse  
Number of Participants  
[units: participants]
 		  318  
Age  
[units: participants]
 		 
<=18 years     318  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  9.1  ± 1.9  
Gender  
[units: participants]
 		 
Female     93  
Male     225  
Region of Enrollment  
[units: participants]
 		 
United States     318  



  Outcome Measures
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1.  Primary:   Change From Baseline in Total Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Score at 7 Weeks   [ Time Frame: Baseline and 7 weeks ]
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2.  Secondary:   Weekly Change From Baseline in Total ADHD-RS-IV Score   [ Time Frame: Baseline and 1, 2, 3, 4, 5, 6, and 7 weeks ]
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3.  Secondary:   Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I)   [ Time Frame: 7 weeks ]
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4.  Secondary:   Number of Participants With Improvement onParent Global Assessment (PGA)   [ Time Frame: 7 weeks ]
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5.  Secondary:   Change From Baseline in Expression and Emotional Scale for Children (EESC) Scores at 7 Weeks   [ Time Frame: Baseline and 7 weeks ]
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6.  Secondary:   Changes From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores at 7 Weeks   [ Time Frame: Baseline and 7 weeks ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Timothy Whitaker, MD
Organization: Shire Pharmaceutical Development Inc
e-mail: twhitaker@shire.com


Publications of Results:
Turgay A, Ginsberg L, Sarkis E, et al. Executive Function Defects in Children with Attention-Deficit/Hyperactivity Disorder and Improvement with Lisdexamfetamine Dimesylate in an Open-Label Study. Journal of Child and Adolescent Psychopharmacology, 20(6):503-511,2010.


Responsible Party: Timothy Whitaker, M.D., Shire Pharmaceutical
ClinicalTrials.gov Identifier: NCT00500071     History of Changes
Other Study ID Numbers: SPD489-310
Study First Received: July 10, 2007
Results First Received: May 26, 2009
Last Updated: January 14, 2011
Health Authority: United States: Food and Drug Administration